Various surgical procedures that are performed on women require that the women's uterus be manipulated such that the physician can view the uterus and cervix properly. Typical of these examinations and procedures would be a complete total laparoscopic hysterectomy, a partial laparoscopic hysterectomy, a colpotomy, as well as other procedures and examinations. Generally, during the performance of a laparoscopic procedure, a small incision is made in the wall of the abdomen and a laparoscope is inserted therethrough to permit visualization of the peritoneal cavity and the uterus.
According to multiple published reports, more than 600,000 hysterectomies are performed annually in the United States alone. Conventional hysterectomy surgical procedures typically involve one of four approaches—vaginal hysterectomy (VH), total abdominal hysterectomy (TAH), total laparoscopic hysterectomy (TLH), and laparoscopically assisted vaginal hysterectomy (LAVH). Vaginal, LAVH, and TLH have become more popular among surgeons because these approaches are less invasive than TAH, with VH being the least invasive approach. Close to 12% of those surgeries are done by a minimally invasive approach or laparoscopically, translating this into more than 70,000 surgeries annually in the United States, alone. VH is considered the least invasive; however, many women are not candidates for VH secondary to large uterus, previous surgery, and presence of adhesions. Unless medical indications require TAH (such as in the case of tumor removal and the associated need to avoid cell spillage), vaginal, TLH and LAVH are usually viewed as more preferable because each is less invasive when compared to major abdominal surgery. Thus, TLH and LAVH approaches usually result in shorter hospitalization and recovery times. With more advance instrumentation and better training of the gynecologic surgeons, the number of hysterectomies is expected to grow ever higher.
Difficulty, however, is encountered when employing TLH and LAVH techniques due to inherent limitations on visibility, anatomical identification, and the ability to manipulate organs (especially the uterus). In the case of TLH, these limitations are particularly pronounced because of higher degree of difficulty in securing the uterine arteries and cardinal ligaments associated with this approach. Altogether, TLH becomes a longer procedure, increasing intraoperative complications risks. During TLH, separation of the uterus and the cervix from the vagina remains one of the most difficult and cumbersome steps of the procedure. A higher degree of surgical difficulty has been found empirically to give rise to an increased risk of inadvertent damage to or dissection into the bladder, ureters, uterine vessels, and uterosacral and cardinal ligaments during the surgical procedure. Although the risk of inadvertent damage, for example, to the ureters can be minimized by the insertion of ureteral stints and/or peritoneal dissection to delineate ureter location, such techniques increase the complexity and the cost of the hysterectomy, and was not found to be effective.
A number of instruments have been developed to assist the physician in visualizing the uterus and facilitating the performance of these various examinations and procedures. Typical of these prior art instruments are those which are described in U.S. Pat. No. 3,926,192 to Van Maren; U.S. Pat. No. 4,000,743 to Weaver; U.S. Pat. No. 4,976,717 to Boyle; and U.S. Pat. No. 4,997,419 to Lakatos et al. The patent to Van Maren is directed to a medical instrument that is inserted into the vagina and passes through the cervix to enter the uterus. A cup-shaped member is provided whose end wall is connected to a source of vacuum, the cup-shaped member including a conical element designed to be placed against the cervical os. The patent to Weaver describes a uterine anteverter that includes an arcuately curved shield, which limits the distance a manipulating arm can be extended into the uterine cavity.
U.S. Patent No. 5,209,754 to Ahluwalia describes a vaginal cervical retractor used to maneuver and visualize the uterus during various medical examinations and procedures. The Ahluwalia device has been commercialized by ConMed Corporation under the title Vcare for the Vaginal-Cervical Ahluwalia Retractor-Elevator.
Available instruments, however, do not address the issue of difficult and time-consuming separation of the uterus and the cervix from the vagina during total laparoscopic hysterectomy. Accordingly, there is a real and unsatisfied need in the surgical arts for a simplified total laparoscopic hysterectomy device that can reduce the time of the surgical procedure, minimize blood loss during surgery, minimize the risk of infection and injury to the patient during surgery, and minimize anesthesia time.